Newsletter - October 6, 2022
A New Bill in the US Congress Aims to Reduce Animal Testing. Will it Work?
This week the US Congress unanimously cleared the Bill S.5002 which requires FDA to allow alternatives to animal testing for drug and biological applications. While there is a strong bi-partisan political support in the US for this bill, in practicality it may have minimal impact on the animal tests required by FDA. Read More
FDA’s List of AI and Machine Learning Devices is an Invaluable Gift
For developers of medical devices using artificial intelligence (AI) and/or machine learning (ML) tools, precedent information is critical. Being a new field, there are few public resources to plan and strategize development steps for FDA approval. FDA’s list of AI/ML-enabled medical devices is hence a priceless gift...Read More
A New Bill in the US Congress Aims to Reduce Animal Testing. Will it Work?
This week the US Congress unanimously cleared the Bill S.5002 which requires FDA to allow alternatives to animal testing for drug and biological applications. While there is a strong bi-partisan political support in the US for this bill, in practicality it may have minimal impact on the animal tests required by FDA. Read More
FDA’s List of AI and Machine Learning Devices is an Invaluable Gift
For developers of medical devices using artificial intelligence (AI) and/or machine learning (ML) tools, precedent information is critical. Being a new field, there are few public resources to plan and strategize development steps for FDA approval. FDA’s list of AI/ML-enabled medical devices is hence a priceless gift...Read More
